Viread

FEATURED ARTICLES ABOUT VIREAD - PAGE 2

NEW DELHI: US drug company Gilead Sciences has filed an appeal in the Indian Intellectual Property Appellate Board (IPAB) to challenge a recent order by an Indian Patent Office that rejected two patent claims for its best seller drug Viread (tenofovir disoproxil fumarate). In August, the Indian Patent Office in Delhi shot down two patents sought by the US firm for Viread after patient groups and Indian company Cipla challenged its patentability. After India ushered in the new patent regime in 2005, the government provides 20-year marketing exclusivity for patented products.

MUMBAI: Domestic pharma major Cipla is opposing US-based biotech major Gilead Sciences' patent application in India for anti-AIDS drug Viread. This is a unique situation, as Gilead has already licenced out marketing rights to 11 domestic companies for this product in India. If Cipla were to win this case, any drugmaker will be able to market a generic version of Vireadhere without having to pay royalty to Gilead. That would raise a question mark over the very purpose of having a licencing agreement.

MUMBAI: Ranbaxy Laboratories Ltd said on Monday that it has entered into a licensing agreement with US-based Gilead Sciences Inc for manufacturing and marketing of Active Pharmaceutical Ingredient (API) and formulations containing anti-HIV drug Tenofovir Disoproxil Fumarate (TDF). While the API would be made available to other Gilead licensees in India, TDF formulations could be marketed in 95 developing countries including India, Ranbaxy informed the BSE. Both API and formulations would be manufactured at Ranbaxy's manufacturing facilities in India.

MUMBAI: Matrix Laboratories has received tentative approval for its abbreviated new drug application Tenofovir Disoproxil Fumarate tablets of 300 mg from the US Food and Drug Administration under the President's Emergency Plan for AIDS Relief. The company is the first to get tentative approval for the generic of Gilead Sciences Inc's 300 mg Viread tablets. The company's ANDA was approved in less than six months and is the seventh under President's Emergency Plan for AIDS Relief in the last 12 months.

NEW DELHI: California-based Gilead Sciences Inc has allowed four Indian companies to make and sell low-cost versions of three of its new HIV drugs under a firstof-its-kind agreement between an innovator pharmaceutical firm and a United Nations-backed patent-sharing body. Under the licensing deal, Ranbaxy Laboratories , Matrix Laboratories , Hetero Drugs and Strides Arcolab can make and sell the three drugs in 100 countries, including India and other developing nations, by paying royalty.

NEW DELHI: Blockbuster AIDS drug Tenofovir is set to get cheaper after its inventor and US patent holder Gilead struck non-exclusive licensing deals with four more Indian drug makers on Thursday. For crores of HIV/AIDS patients, the annual cost of treatment using tenofovir disoproxil fumarate (generic name) is set to fall from about Rs 60,000 to about Rs 16,000 in the coming days as the price war heats up. The drug blocks an enzyme which the virus needs to embed itself in a healthy cell and to programme itself to replicate.

MUMBAI: Pharmaceutical companies in India seem to be conducting a few experiments outside their labs too. Among the new initiatives are clever product sharing arrangements with their rivals, so that the cost of development is spread among many players. Also, each of them benefits because a large number of doctors are informed about the product by a large sales army. Companies like Gujarat's Alembic, Hetero Drugs of Hyderabad and Mumbai-based Lupin have forged such alliances, sources say. Experts in pharmaceutical marketing say the trend of companies coming together to collectively push their products is natural as the industry faces pressures of consolidation.

The battle lines between Western pharmaceutical transnationals and NGOs and patients' associations are now drawn sharper than ever before. At the core of the dispute are attempts to get patents for anti-AIDS drugs. NGOs, along with groups of people living with AIDS, are fighting pharma MNCs trying to patent their anti-AIDS drugs in India. So far, 12 anti-AIDS drugs for which patents are being sought by pharma MNCs have been opposed, sources said. The Indian Network for People Living with HIV/AIDS (INP)

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